American College Of Surgeons - Inspiring Quality: Highest Standards, Better Outcomes

Federal and State Regulatory and Legislative Issues

ACS Releases New Telehealth Resources

The use of telehealth and other virtual services is critical to reducing exposure to the COVID-19 virus and ensuring continuity of care for individuals with chronic conditions during this public health emergency (PHE). To help surgeons navigate and integrate virtual services into their practices and enhance their ability to safely care for patients during the COVID-19 pandemic, the ACS has developed resources that describe coverage and reimbursement rules for virtual services from both Medicare and private payors; Health Insurance Portability and Accountability Act (HIPAA) privacy and security rules applicable to telehealth during the PHE; and various telehealth products available for use by physicians. For more information, contact Lauren Foe at lfoe@facs.org.

Practice Protection Committee Hosts Webinar on Contracts and Financial Resources

The American College of Surgeons (ACS) Practice Protection Committee hosted its second webinar Monday night. The theme of this webinar was Contractual Considerations and Hospital Relations. An update on available financial resources also was provided. Among the topics discussed relative to financial resources was the Centers for Medicare & Medicaid Services’ April 26 announcement of an abrupt halt to the Medicare Advance Payments Program.

Attorney Stacy L. Cook, partner at Barnes and Thornburg, LLC, presented information on questions and concerns surgeons may have relative to provisions in their employment contracts or contracts for professional services. In addition, former ACS Board of Regents Chairs Michael Zinner, MD, FACS, and Julie Freischlag, MD, FACS, along with Peter Austin, Chief Operating Officer, Jefferson Regional Medical Center, Pine Bluff, AR, answered questions about how their institutions have sought to maintain surgeon employment during the pandemic as well as on other topics related to hospital relationships. A recording of the webinar can be found here.

Surgical Coalition Urges Delay of Payment, Health IT Rules

The 21 members of the Surgical Coalition sent a letter April 24 to the U.S. Department of Health & Human Services, the Centers for Medicare & Medicaid Services (CMS), and the Office of the National Coordinator (ONC) for Health Information Technology requesting delayed implementation of certain regulations in light of the COVID-19 public health emergency (PHE). The letter centers on the Quality Payment Program (QPP), the interoperability of health care records, and other health information technology (IT) issues.

QPP recommendations are as follows:

  • Extend the automatic extreme and uncontrollable circumstances policy for all QPP participants for the calendar year (CY) 2020 performance year to allow physicians time to rebuild their practices post-COVID-19.
  • Delay implementation of the new Merit-based Incentive Payment System Value Pathways framework to reduce burdens on physicians during the public health emergency and allow extra time for clear programmatic details to be developed.
  • No public reporting of QPP data for the 2019 or 2020 performance years.

Comments on CMS’ final rule on Advancing Interoperability and Patient Access to Health Data are as follows:

  • Delay public reporting of clinicians’ responses to the Promoting Interoperability information blocking attestation on Physician Compare and eliminate requirements to report on the 2019 and 2020 performance years.
  • Delay for one year the policy that requires the public reporting of digital contact information in the CMS National Plan and Provider Enumeration System.

Comments on the ONC final rule on Interoperability, Information Blocking, and the ONC Health IT Certification Program include:

  • Delay information blocking enforcement for at least six months, which would make the information blocking policy applicable, at the earliest, within 12 months after the rule is published in the Federal Register.
  • Take into consideration the PHE and any associated delays in the enforcement of the information blocking provisions when determining the appropriate type and implementation date of provider disincentives through future rulemaking.

HHS Offers Guidance on Payment, Testing, PPE, and Other Critical Issues

The U.S. Department of Health and Human Services (HHS) April 27 issued updates on various issues of concern to health care professionals at this time. A summary can be found here:

Provider portal open to bill for uninsured: The Health Resources and Services Administration launched a new COVID-19 Uninsured Program Portal, allowing health care providers who have conducted COVID-19 testing or provided treatment for uninsured COVID-19 individuals on or after February 4 to request claims reimbursement. Providers can access the portal at COVIDUninsuredClaim.HRSA.gov and there is also an FAQ document on the portal and information for providers.

Expanding serological testing capacity: BARDA and InBios International, Inc. have partnered to expedite development for serological tests to identify asymptomatic or recovered cases of COVID-19. The Food and Drug Administration (FDA) also approved four emergency use authorizations (EUA) from Abbott Laboratories, DiaSorin, Ortho-Clinical Diagnostics, and Autobio Diagnostics, Inc.

Collecting and distributing blood plasma: BARDA is supporting America’s Blood Centers to coordinating the collection and distribution of convalescent plasma for therapeutic use in treating COVID-19 hospitalized patients.

Update on therapeutics: The Centers for Disease Control and Prevention (CDC) updated its Information for Clinicians on Investigational Therapeutics for Patients with COVID-19. Individuals seeking information about registered clinical trials for COVID-19 in the U.S. are encouraged to go to www.clinicaltrials.gov

Distribution of cloth face coverings: Federal agencies are distributing cloth face coverings as part of a multi-prong approach to reopen American economic activity while continuing to limit spread of COVID-19. As of April 26, 32.5 million cloth face coverings are being processed and distributed to state, local, tribal, private sector, and federal entities.

Face mask updates: The FDA is reissuing its EUA letter on face masks to clarify that face masks, including cloth face coverings, are authorized to be used by health care personnel only as source control.

PPE preservation best practices: The Federal Emergency Management Agency (FEMA) released a factsheet on best practices for preserving personal protective equipment (PPE), while ensuring the protection of workers during the COVID-19 pandemic response.

Reusing filtering facepiece respirators: The Occupational Safety and Health Administration released guidance on the reuse of filtering facepiece respirators that have been decontaminated through certain methods. This guidance applies in workplaces in which workers need respirators to protect against exposure to infectious agents that could be inhaled into the respiratory system, including during care of patients with suspected or confirmed COVID-19 infection and other activities that could result in respiratory exposure to SARS-CoV-2.

CMS suspending Medicare Advance and Accelerated Payment Program: The Centers for Medicare & Medicaid Services (CMS) is reevaluating the amounts that will be paid under its Accelerated Payment Program and suspending its Advance Payment Program to Part B suppliers effective immediately. The agency made this announcement following the successful payment of over $100 billion to health care providers and suppliers through these programs and in light of the $175 billion recently appropriated for health care provider relief payments. Beginning April 26, CMS stopped accepting any new applications for the Advance Payment Program and will be reevaluating all pending and new applications. More information on the program can be found here. 

Mental health grants: SAMHSA (Substance Abuse and Mental Health Services Agency) announced that grants have been awarded to increase access to and to improve the quality of community mental and substance use disorder (SUD) treatment services through the expansion of Certified Community Behavioral Health Clinics (CCBHC). The fiscal year 2020 CCBHC Expansion Grants include $200 million in annually appropriated funding and $250 million in emergency COVID-19 funding. The grant awards are listed on the SAMHSA website.

Pausing nursing home Five Star Quality Rating System: CMS announced via a memo that the inspection domain of the Nursing Home Compare website will be held constant temporarily due to the prioritization and suspension of certain surveys, to ensure the rating system reflects fair information for consumers. In addition, CMS is releasing information that shows the average number of staff each nursing home has on-site, each day (nursing staff and total staff), and aggregated by state and nationally. Along with these announcements, CMS released a list of Frequently Asked Questions to clarify certain actions the agency has taken related to visitation, surveys, waivers, and other guidance.

Waiver flexibility: CMS has approved more than 125 requests for state relief in response to the COVID-19 pandemic, including recent approvals for Arizona, Illinois, Iowa, Louisiana, Maine, Maryland, Nebraska, New Mexico, North Carolina, Oregon, Rhode Island, and Washington. These approvals help to ensure that states have the tools they need to combat COVID-19 through a wide variety of waivers, amendments, and Medicaid state plan flexibilities, including for programs that care for the elderly and people with disabilities. CMS developed a toolkit to expedite the application and review of each request and has approved these requests in record time. 

Infection control guidance to home health agencies: CMS issued guidance to respond to questions from Medicare & Medicaid Home Health Agencies and Religious Nonmedical Healthcare Institutions. The guidance addresses the COVID-19 outbreak and minimizing transmission to other individuals.